Evaluation of a Spherical Hydrophilic Acrylic Intraocular Lens

NCT04998409 | Completed

• 1 other identifier: SPHERIS 209 BER-401-20
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens

Conditions

Cataract Senile

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  Monocular visual acuity at far distance (4m) using sloan letters

  12 to 24 months after the implantation

Study Arms (1)

Monofocal IOL

Device: Monofocal lens

Interventions

Monofocal lens DEVICE

not applicable as patients are already implanted with the monofocal lens

Monofocal IOL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients implanted with the study lens

You may qualify if:

• Patients of any gender, aged 18 years or older at the time of the surgery
• Patients who had an uncomplicated (no intra-operative complication) aged-related cataract surgery
• Currently implanted with the study IOL into the capsular bag in at least one eye
• One-year post surgery follow-up (365 days -14 days/+365 days) for the study eye at the time of the postoperative visit
• Patient is willing and capable of providing informed consent
• Patient is willing and capable of complying with visits and procedures as defined by this protocol

You may not qualify if:

• Preoperative corrected distance visual acuity (CDVA) better than 0.3 LogMAR (0.5 decimal) or CDVA not available preoperatively
• Preoperative documented endothelial cell count of less than 2000/mm2 (if available)
• Any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss
• Any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
• Any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies)
• Any preoperative documented clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
• Any preoperative documented history of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis
• Any preoperative acute infection (acute ocular disease, external/internal infection, systemic infection)
• Any previous preoperative intraocular and corneal surgery
• Preoperative documented uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment
• Preoperative documented or current systemic or ocular pharmacotherapy that effects patients' vision
• Any other preoperative documented or current pathology or condition that could be a risk for the patient according to the investigator opinion
• Women during pregnancy and/or lactation at time of enrollment into the study
• Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
• Patients whose freedom is impaired by administrative or legal order

Sponsors & Collaborators

• Carl Zeiss Meditec AG: lead

Study Sites (1)

Augenklinik Rosenheim

Rosenheim, 83022, Germany

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 10, 2021
• Study Start: September 24, 2021
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

DE (1)